Cleared Traditional

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct

K242494 · Riverpoint Medical, LLC · Orthopedic
Nov 2024
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K242494 is an FDA 510(k) clearance for the OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical, LLC (Portland, US). The FDA issued a Cleared decision on November 26, 2024, 96 days after receiving the submission on August 22, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K242494 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2024
Decision Date November 26, 2024
Days to Decision 96 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040